Rapid laparoscopy exchange system and method of use thereof

ABSTRACT

A system for positioning an interchangeable tool in a body cavity includes a channel having a lumen in direct communication with the body cavity; a tool introducer having a longitudinal axis and a distal end, the tool introducer capable of traveling through the channel lumen; and a tool holder covering at least a portion of the interchangeable tool that is pivotally connected to the tool introducer allowing angular positioning of the interchangeable tool after the tool holder emerges from the channel into the body cavity. A method for engaging an interchangeable tool with a distal portion of a tool manipulator in a body cavity includes inserting a tool introducer into a channel, orienting the distal portion of the tool manipulator in the body cavity; emerging the interchangeable tool from the channel into the body cavity; and positioning the interchangeable tool eccentrically to the lumen of the channel.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/274,281 filed on May 9, 2014, which is a continuation of U.S.application Ser. No. 13/010,661 (issued as U.S. Pat. No. 8,721,539),filed on Jan. 20, 2011, which claims priority to U.S. ProvisionalApplication No. 61/296,485, filed Jan. 20, 2010, both entitled RapidLaparoscopy Exchange System And Method Of Use Thereof, and both of whichare hereby incorporated by reference herein in their entireties.

FIELD OF THE INVENTION

The present invention generally relates to surgical methods and devices,and more specifically to laparoscopic and/or any endoscopic relatedsurgical interventions.

BACKGROUND OF THE INVENTION

Laparoscopic or minimally invasive surgery includes the use of severalrelatively small ports into the abdomen by which different types ofinstrumentation and accessories are introduced and used for differentsurgical interventions (usually performed under endoscopic vision).Although usually considered superior in several aspects to open surgery,the use of plurality of 5 to 15 mm ports still leads to local pain,scars, and possibly port related complications such as hernia in scarsand the need for one or two assistants in addition to the surgeon.Laparoscopic methods and surgical device are described, for example, inU.S. Pat. Nos. 5,980,493, 7,593,777 and 7,316,699, the disclosures ofwhich are fully incorporated herein by reference.

In past years, new versions of laparoscopic systems and approaches wereintroduced to overcome several of the “classic” laparoscopydisadvantages, mainly the Single-Port Access (SPA) and the Needlescopyapproaches. In SPA the surgeon operates almost exclusively through asingle entry point, typically through the patient's navel, using accessports and hand instrument. Highly experienced and skilled physicians maystill use standard laparoscopic hand instruments, although the use of asingle port access decreases its triangulation and complicatesmaneuverability. The use of special-purpose articulating instrumentationwas introduced to overcome this difficulty, although it is consideredvery expensive, necessitates special training and still involves complexsurgical maneuverability.

Minilaparoscopy/needlescopic laparoscopy is intended to overcome theproblems encountered in single port access surgery. While the advantagesof SPA includes improved cosmetic, less abdominal wall pain and lessincision related complications, this surgical approach has itsdisadvantages. The vision is partially obscured by the paralleledinserted instruments; there is minimal triangulation and limitedmaneuverability of the surgical instruments. Minilaparoscopy maintainsthe same mode of surgery as standard laparoscopy however there is onlyone trocar and all the rest of the instruments are connected to needlelike shafts which are inserted with no trocar and therefore providecomparable cosmetic and painless results as SPA.

In needlescopy, the laparoscopic ports are replaced with smallincisions, usually between 2 to 3 mm in diameter. The surgery isperformed by inserting narrow guide tubes into the small incisions andthen passing tiny instruments through the tubes, while using a smalltelevision camera for guidance. The small instruments have very slendertips which make dissection and tissue maneuvration very difficult.Furthermore the instrument tips may have a greater tendency to break andtheir removal may be cumbersome and difficult.

In order to avoid such difficulties while maintaining small incisionporting, it has been advised to combine the single-port and theneedlescopic approaches. This is achieved by first insertingregular-sized interchangeable end-effectors through a regular sizesingle port access and then detachably attaching them to correspondingdistal portions of needle-sized manipulators. The manipulators areprotruding into abdomen cavity via miniature needlescopic typeincisions. The concept and several device derivatives were described inthe following patents, the disclosures of which are fully incorporatedherein by reference.

U.S. Pat. No. 5,352,219 to Reddy describes a two-part modular tool andmethod for use thereof in conjunction with laparoscopic techniquesenhances such techniques by enabling tools to be manipulated within abody cavity through small needle holes. The tool has an instrument headinitially inserted through a laparoscopic port and an acuminate shaftwhich intracorporeally attaches to the instrument head. The instrumenthead is then manipulable through the needle hole at the site of desireduse. The instrument head may be any tool configuration useful insurgical procedures which can be miniaturized to pass through alaparoscopic port.

U.S. Pat. No. 5,441,059 to Dannan describes a method of conductingminimally invasive surgery that includes the steps of making a primaryincision; importing at least one surgical instrument head through theprimary incision; making at least one secondary incision, smaller thanthe primary incision and the cross-section of the surgical instrumenthead, for a handle; extending the distal end of the handle through eachsecondary incision; attaching one of the surgical instrument heads tothe distal end of the handle; manipulating the surgical instrument headwith the handle to which it is attached; detaching the surgicalinstrument head from the handle; removing the surgical instrument headthrough the primary incision; and withdrawing the distal end of thehandle from the secondary incision.

U.S. Pat. No. 6,723,043 to Kleeman et al. describes a surgicalinstrument assembly that includes an operative element and an insertioninstrument removably engageable to the operative element. The insertioninstrument is positionable in a patient with the operative elementengaged thereto to position the operative element at an operative sitein the patient. A transfer instrument is removably engageable to theoperative element when the operative instrument is located at theoperative site. The insertion instrument can then be removed. Methodsfor using the surgical instrument assembly are also disclosed.

SUMMARY OF THE INVENTION

In a broad aspect of some embodiments there is provided a laparoscopicsystem applicable for delivering, guiding and/or coupling aninterchangeable laparoscopic end-effector (e.g., surgical tool) to adistal portion of a tool manipulator in a body cavity. Appropriatelyutilizing the system may constitute a shorter duration, reduceduncertainty and improved safety of procedure preparation and initiation.

In some embodiments, the interchangeable surgical tools are of regularlaparoscopic size and are sequentially deliverable though a singleregular laparoscopic port (usually between 5 and 10 mm in diameter).Once delivered into body cavity, each surgical tool may then beconnected to a slender shaft manipulator having a diameter of 5 mm orless, optionally about 2 mm or less. The surgical tool may be connectedto the manipulator distal end by a variety of interlocking means,including snap-lock mechanisms.

Optionally, a tool introducer may be used to position theinterchangeable surgical tool in a chosen operation site within bodybefore coupling to a tool manipulator. The introducer or manipulatordistal end may have a pivoting connection to the surgical tool. Anintroducer pivoting distal end may be selectively angled by remotemanipulation.

In some embodiments, at least one endoscope and/or camera may beintroduced via the laparoscopic port to monitor surgical procedureand/or tool guidance and transfer between introducer and manipulator. Anendoscope may have an angled or beveled tip for viewing the process ofconnecting between tool and manipulator. An endoscope/camera may beinserted through the port/trocar any time before or after the toolintroducer is positioned there. In some embodiments, the laparoscopicsystem includes a special purpose monitoring endoscope: besides using acamera to monitor procedure as custom in laparoscopic procedures, aspecial purpose endoscope (which may be a standard/commerciallyavailable or specially designed endoscope) may be advanced via anintroducer inner lumen for monitoring adaptor/interlocking operation. Insome embodiments, a detachable mini-camera optionally in the form of acapsule or an end-effector is percutaneously introduced into the bodycavity in a minimally invasive technique (e.g., using a toolintroducer), and connected to a previously introduced tool holders(e.g., a distal end of a tool manipulator).

In some embodiments, the laparoscopic system includes an externalguiding template indicating specific insertion ports for trocar and/ormanipulators. Optionally, each port is specifically designed to guide amanipulator to a specific orientation within body for a rapid andaccurate in-vivo coupling to an interchangeable end-effector. Theoperator may selectively choose between a fixed manipulator guiding,that is relevant for manipulator introduction into body and engagingwith the effector, and a free manipulator movement, relevant for propersurgical intervention. A template frame may be procedure-specific and/orpatient-specific (and allow all possible relevant ports) or adjustableaccording to need. It may be operated manually and/or remotely. Beneathor included in the template frame, there may be an adhesive sealantcloth and/or pad that provides adequate sealing around port/incision toavoid contamination and C02 leakage.

In some embodiments, the laparoscopic system includes a needlescopicmanipulator supporting mechanism capable of setting a specific chosenposition of a miniature element (e.g., effector or camera) within body.The supporting mechanism may be operated manually or robotically, andallow fixedly 3O orientation change of the miniature elementmanipulator/holder (slender shaft/handle). The supporting mechanism maybe a truss-based mechanism or a ball-socket mechanism; may include aratchet mechanism and may be implemented in the external guidingtemplate, for example in or in association to at least one of its ports.

In some embodiments, the laparoscopic system includes a surgical toolvectoring mechanism selectively and/or automatically altering introducerdistal end when/after the effector is protruding into body through thetrocar, in order to facilitate accurate and rapid engagement withmanipulator distal end. The vectoring mechanism may allow an accurate,timely direction shift of the surgical tool/effector with respect totool-holder longitudinal axis. Optionally, the tool is detachable fromthe introducing tool holder, and is further connectable to a second toolholder (e.g., a manipulator) that is substantially parallel and/orcollinear and/or concentric with respect to a receiving portion of thetool/adaptor after the said direction shift. The vectoring mechanism maybe passive (e.g., using a spring/nitinol set to shift the tool to apredetermined direction), or active/adjustable (e.g., eithermechanically—for example by maneuvering the introducing tool holderalong the trocar path, or electronically/robotically—after the tool iscompletely protruding through the trocar).

Optionally, an end-effector may be coupled to manipulator using rapidinterlocking means (e.g., snap locking means). In some embodiments, thelaparoscopic system includes a “handoff” coupling mechanism, i.e., adouble-action locking mechanism allowing secure passing between twoend-portions of laparoscopic slender shafts (e.g., trocars,manipulators, introducers, etc.) whereby the effector is released fromintroducer only after interlocking with manipulator and vice versa.Optionally, a special tool removal device may be used for detaching aneffector to/from a manipulator, or this may be performed by the toolintroducer itself.

According to an aspect of some embodiments there is provided a systemfor positioning an interchangeable tool in a body cavity, the systemcomprising:

a channel comprising a lumen in direct communication with the bodycavity;

a tool introducer comprising a longitudinal axis and a distal end, thetool introducer is capable of traveling through the channel lumen; and

a tool holder covering at least a portion of the interchangeable tool,the tool holder is pivotally connected to the tool introducer distalend, thereby allowing angular positioning of the interchangeable toolafter the tool holder emerges from the channel into the body cavity.

In some embodiments, the angular positioning is predetermined.Alternatively and/or additionally, the angular positioning is constant.Alternatively and/or additionally, the angular positioning isselectively chosen after the tool holder emergence into the body cavity.

In some embodiments, the interchangeable tool includes a passage foraccommodating a distal portion of a tool manipulator. Alternativelyand/or additionally, the angular positioning positions the passage withrespect to the distal portion of the tool manipulator. Alternativelyand/or additionally, the passage is concentric to the distal portion ofthe tool manipulator after the angular positioning.

In some embodiments, the interchangeable tool comprises one of the groupconsisting of a grasper, a dissector, a needle holder, scissors, acamera, an endoscope, a heat source, a sensing probe, a cryogenic probe,a dissector, a biopsy probe, a cutting tool, a laser source, an IRsource, a light source, an illumination source, an ultrasound probe, anelectrocautery device, a drug delivery device and combinations thereof.

In some embodiments, the system further comprising an external guidingdevice configured to guide a tool manipulator to engage theinterchangeable tool in the body cavity, wherein the guiding devicecomprises:

a center guide comprising a first lumen adapted to accommodate thechannel;

an adjustable peripheral guide having a proximal end connected to thecenter guide and a distal end incorporating a second lumen; wherein:

the tool introducer is distally connected to the interchangeable tooland readily deployed in the body cavity through the channel accommodatedin the first lumen of the center guide; and

the adjustable peripheral guide is adjusted to guide the toolmanipulator through the second lumen to engage the interchangeable tool.

In some embodiments, the external guiding device is further adapted toguide a distal portion of the tool manipulator in a defined orientationand/or depth in the body cavity. Alternatively and/or additionally, theexternal guiding device is adapted to selectively lock the distalportion of the tool manipulator in the orientation and/or depth.Alternatively and/or additionally, the distal portion of the toolmanipulator is concentric to an inner passage of said interchangeabletool.

In some embodiments, the second lumen includes a longitudinal axis thatis angled towards the center guide in at least one dimension.

In some embodiments, the adjustable peripheral guide is adjustable by atleast one of: lengthening, bending, tilting, rotating, deforming and/orany combination thereof.

In some embodiments, the interchangeable tool is tilted with respect tothe tool introducer.

In some embodiments, the system further comprises an external framecomprising at least one external guiding device.

In some embodiments, the tool holder is a tool cartridge.

In some embodiments, the tool introducer comprises a tubular section.Alternatively and/or additionally, the tubular section further comprisesan endoscope deployable in the tubular section. Alternatively and/oradditionally, the tubular section includes a window, thereby enablingendoscopic visualization by the endoscope.

According to an aspect of some embodiments there is provided a methodfor engaging an interchangeable tool, the tool having an inner passage,with a distal portion of a tool manipulator in a body cavity, the methodcomprising the steps of:

inserting a tool introducer into a channel, the channel comprising alumen providing direct communication into the body cavity and wherein aproximal end of said interchangeable tool is reversibly connected to adistal end of the tool introducer;

orienting the distal portion of the tool manipulator in the body cavity;

emerging the interchangeable tool from the channel into the body cavity;and positioning the interchangeable tool eccentrically to the lumen ofthe channel

wherein the inner passage of the interchangeable tool is angled towardsthe distal portion of the tool manipulator.

In some embodiments, the positioning is automatically executed once theinterchangeable tool entirely emerges from the channel. Alternativelyand/or additionally, the positioning is selectively executed by anoperator.

In some embodiments, the method further comprising predetermining anangle of the positioning of the interchangeable tool. Alternativelyand/or additionally, the method comprising using a constant angle forthe positioning of the interchangeable tool. Alternatively and/oradditionally, the method further comprising selectively choosing anangle of the positioning of the interchangeable tool after emerging theinterchangeable tool. Alternatively and/or additionally, the innerpassage of the interchangeable tool is concentric to the distal portionof the tool manipulator after the positioning.

In some embodiments, the orientating step is accomplished by means of anexternal guiding device.

In some embodiments, the method further comprises the steps:

advancing the distal portion of said tool manipulator to engage with theinner passage of the interchangeable tool; and

engaging the distal portion of the tool manipulator with the innerpassage of the interchangeable tool. Alternatively and/or additionally,the method further comprising the steps of locating the distal end ofthe tool manipulator before introducing the interchangeable tool by:

introducing an elongated tool introducer through the lumen into the bodycavity and moving the distal end of the tool introducer into a positionadjacent to a position to which the distal portion of the toolmanipulator is oriented and guiding the distal end of the toolmanipulator to engage with the inner passage when the interchangeabletool is emerged into the body cavity

and/or

introducing an elongated channel, the channel comprising a lumen, intothe body cavity and moving the distal end of the elongated channel intoa position in the body cavity adjacent to a position to which the distalportion of the tool manipulator is oriented and guiding the distal endof the tool manipulator to engage with the inner passage when theinterchangeable tool is emerged into the body cavity; and

advancing the distal portion of tool manipulator to engage with theinner passage.

In some embodiments, the method and further comprising the step ofcapturing the distal end of the tool manipulator at an entry point ofthe tool manipulator as the distal end of the tool manipulator emergesinto the body cavity and before the distal end of the tool manipulatormoves substantially into the body cavity by utilizing the elongated toolintroducer and/or the elongated channel having an lumen.

In some embodiments comprising monitoring the engaging procedure via anendoscope situated in a tubular section of the tool introducer.

In some embodiments, the interchangeable tool is housed in a toolholder.

In some embodiments, the first lumen is a laparoscopic port having adiameter that is equal or more than 5 mm. In some embodiments, thesecond lumen is a needlescopic port having a diameter that is equal orless than 3 mm. Optionally, the second lumen includes a longitudinalaxis that is angled towards the center guide in at least one dimension.Optionally, the adjustable peripheral guide is adjustable by at leastone of: lengthening, bending, tilting, rotating, deforming and/or anycombination thereof. Optionally, the interchangeable tool is tilted withrespect to the tool introducer.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIGS. 1A-B illustrate rapid laparoscopy system in operation, and acorresponding zoom-in portion, in accordance with an exemplaryembodiment of the present invention;

FIG. 2 illustrates a rapid-laparoscopy external template, in accordancewith an exemplary embodiment of the present invention;

FIGS. 3A-H illustrate several deployment possibilities of arapid-laparoscopy external template, in accordance with an exemplaryembodiment of the present invention;

FIGS. 4A-B illustrate exemplary prior-art and an optional laparoscopicports schemes, in accordance with an exemplary embodiment of the presentinvention;

FIGS. 5A-F illustrate an exemplary interchangeable tools insertionsystem and steps of introduction thereof, in accordance with anexemplary embodiment of the present invention;

FIGS. 6A-B illustrate a side view and a corresponding top cut-view of atool nested in an introduced cartridge, in accordance with an exemplaryembodiment of the present invention;

FIGS. 7A-C illustrate several interlocking possibilities to a tool, inaccordance with an exemplary embodiment of the present invention;

FIG. 8 illustrates a side view of a tool connected to manipulator, inaccordance with an exemplary embodiment of the present invention;

FIG. 9 illustrates a side view of a tool connected to a manipulatorpressed against a tool cartridge, in accordance with an exemplaryembodiment of the present invention;

FIGS. 10A-F illustrate several regular and cut views of toolinterlocking with a cartridge and release from a manipulator, inaccordance with an exemplary embodiment of the present invention; and

FIGS. 11A-C illustrate two alternative ways of positioning a trocar anda tool-introducer inside the body cavity for safely connecting aninterchangeable tool to a manipulator, in accordance with an exemplaryembodiment of the present invention.

DETAILED DESCRIPTIONS OF EXEMPLARY EMBODIMENTS

(a) Exemplary Rapid Laparoscopy System

FIG. 1 illustrate an exemplary rapid laparoscopy system 100 deployed inpatient body 200 (shown in a “sliced” proportion for demonstrativepurposes), the system includes an introducing sleeve 110 and at leastone tool manipulator 140. In some embodiments, sleeve 110 is a trocarhaving a tubular body 112 and a substantially sharp or blunt distal endthat is capable of channeling a surgical tool 130 into a cavity withinbody 200 using a tool introducer 120. Sleeve 110 may be of any preferredsize, and usually between 3 to 20 mm in diameter, optionally 5 to 10 mm(e.g., similar in size to regular laparoscopic port). Sleeve 110 may besized (e.g., smallest cross section) to accommodate a largest of tools130 in a specific tool kit. In some embodiments, system 100 includes asingle regular-sized laparoscopic port that may be utilized for tool(s)130 insertion into body and/or connection to manipulator(s) 140.

Tool 130 may be any operational element (e.g., a probe or an instrument)deployable within a body, including but not limited to: surgical tools,grasping elements, dissectors, needle holders, clippers, scissors,connecting (e.g., stapling) elements, biopsy related instruments, sensorelements, imaging elements, clamping or grasping devices, heatgenerating probes (including RF, laser, IR, light, etc.), cryogenicprobes, cutting and dissecting devices or energy sources, ultrasoundprobes, etc. In some embodiments, tool 130 is interchangeable and may bereleasably attached to a distal tip 146 of manipulator 140, as shown inFIG. 1B. In some embodiments, tool 130 includes a tool head or effector132 (e.g., grasping means as presently illustrated), a body 134 and aninner passage 136 for accommodating a manipulator distal tip 146. Insome embodiments, tool 130 further includes locking mechanism (notshown) that allows safe coupling to manipulator 140.

In some embodiments, introducer 120 includes a tubular body 122, with anoptional distal projection (optionally, tail-like), that is associatedwith (e.g., connected to, for example by using a Babcock grasper) tool130. In some embodiments, tool introducer 120 is releasably connected totool 130 and/or to any sort of adapter or cartridge 124 (shown in FIG.5) that may be associated with (e.g., connect to or contain) tool 130until deployment and/or operation. In some embodiments, introducer 120allows a defined 3O orientation of tool 130 within body, thus providinga simpler and a potentially rapid approach for engaging manipulator 140with inner passage 136 of tool 130. Optionally, tool 130 orientation isselectively chosen, optionally adequately accurate. Optionally, tool 130is oriented to a specific predefined position, for example by using apivoting mechanism that combines spring energy and motion limiting (notshown). Alternatively or additionally, tool orientation is achieved bymanual or computerized operation, either remotely or at site. In someembodiments, introducer 120 and/or any associated tool holder, adapteror cartridge, further includes a safe tool passing mechanism (notshown), optionally a “handoff” type mechanism, which allows release oftool 130 only after the latter is safely interlocked with manipulator140, and optionally vice versa.

In some embodiments, manipulator 140 includes a shaft 142, distal tip146 and a tool operating handle 144. Shaft 142 and tip 146 largest crosssection may be 0.5 to 5 mm in diameter, optionally 1 to 2.5 mm,optionally about 1 mm, about 1.5 mm or about 2 mm or higher or lower orintermediate. Tip 146 is optionally sharp and/or pointed in order toallow at least one of tissue penetration and easier engagement into toolinner passage 136. Optionally, tip 146 is a Veres needle whichoptionally permits penetration through skin and abdominal wall tissuewhile preventing injury of internal organs (e.g., bowels), when not“armed”. Optionally, tip 146 includes interlocking means, e.g.,threading or a groove for snap-locking (not shown), for firmlyconnecting with tool 130. Handle 144 may be any manually operated typelaparoscopic instrumentation handle or may be replaced with any roboticor other non-manually operated arm. In some embodiments, handle 144includes mechanisms which operates tool 130 and/or their association(e.g., locking or releasing modes or operations).

At least part of the instruments are made from rigid biocompatiblematerials as known to a person skilled in the art, and may includestainless steel, optionally hardened or reinforced by carbon coating orfibers, ceramic materials, plastic/polymeric materials (e.g., PEEK),composite materials (e.g., carbon-epoxy), or any combination thereof.

In some embodiments, rapid laparoscopy system 100 further includes atleast one, and preferably at least two, intraoperative imaging devices(e.g., microcameras and/or endoscopes), at least one of which can beused to monitor tool 130 transfer, locking and/or handoff fromintroducer 120 to manipulator 140, and optionally vice versa.Optionally, tool handoff monitor is an endoscope 128 (as shown in FIG.5) located within or adjacent to trocar 110 and/or introducer 120.Additionally or alternatively, a grasped microcamera is transferred intobody via trocar 110 using introducer 120 and then handed over to one ofmanipulators 140 which locates it in a preferred position to monitor thesurgical operation. Other microcameras and/or endoscopes may be deployedin other locations using different manipulators.

In some embodiments, manipulator 140 is supported with an externalholding device 150 which allows selective locking of manipulator in acertain positioning. This may be especially advantageous for examplewhen a physician chooses to fixate a tool (e.g., a grasper) in a certainposition while avoiding any unnecessary movements for a chosen period oftime, and/or when he needs to occupy his hands with othermanipulator(s). Holding device 150 may use a manipulator shaft grasperassociated with a locking and/or guiding elements (not shown), therebyallowing selective alternating between a free movement mode and aposition locking/guiding mode.

Reference is now made to FIG. 2 showing patient body 200 setting priorto a rapid laparoscopy procedure using an exemplary external holdingdevice 150 in a form of template. In some embodiments, device 150includes a template frame 154, a single tool introducer opening 156 anda plurality of manipulators openings 158. Frame 154 includes severalextensions upon which laparoscopic instrumentation may be supported, theextensions may be provided in a predefined design according to aspecific instrumentation allocation pattern (as derived from a specificsurgical method) or may be assembled or manipulated (e.g., manually,electronically or other) to a different chosen arrangement.

Frame 154 may have a curved base for improved fitting over patient body200 and/or may include fastening elements (not shown), such as fasteningbelts, for a firmer connection to patient body 200. Frame 154 may bemade from any rigid or semi-rigid material, including metals, plasticsand polymers.

External holding device 150 may include introducer-manipulatorscoordinating means which allow accurate manipulator engagement with atool-head within body by guiding the manipulator in a specificcorrelated angle, plane and/or depth with respect to the tool head.

Exemplary holding device 150, as specifically illustrated in FIG. 2, isadapted for a single-port micro-laparoscopic procedure in which a singleregular-sized laparoscopic port is used for delivering regular-sizedlaparoscopic instrumentation into body to be assembled to and operatedwith micro-sized, “needlescopic”, manipulators. Accordingly, in someembodiments, tool introducer opening 156 is approximately 5 to 15 mm indiameter (although it may be changed to or replaced with to differentsizes according to need) in order to allow regular sized tools andendoscope(s) as accustomed in “classic” laparoscopy approaches.Furthermore, in some embodiments, manipulators openings 158 areapproximately 1 to 2.5 mm in diameter in order to allow needlescopicmanipulation of tools within body with substantially lessened scarringeffect of body 200.

Exemplary holding device 150 may include or be provided with a sealingpad or sheath 152 that may be especially useful in order to seal anyentrapped gaseous substances (e.g., C0₂) within cavity of body 200,and/or for protecting against any potential contamination as may beresulted in case of directly communicating with open air. Sealing pad152 may be made from any relatively pliant or elastic material such assoft polymer or silicone, while maintaining re-sealing capabilities whenpierced with a micro-sized element, such as a needle (similarly to aseptum seal).

Device 150 may serve as a needle introducer template using specificpre-set orientation means. This may be advantageous especially for rapidlocation and handoff of tool 130 from introducer 120 to manipulator 140,as device 150 may be used to guide manipulator distal tip 146 adequatelyaccurately towards tool inner passage 136. An exemplary pre-setorientation means are illustrated in FIGS. 3A-B, in which toolmanipulator 140 is operated through manipulator opening 158 and aportion of sealing pad 152. As shown in FIG. 3A, a needle guidingelement 148 is placed over a portion of shaft 142 and maintains aspecific orientation according to a preformed design of opening 158.Optionally, guiding element 148 is a sleeve, optionally a splittingsleeve, and is made of a relatively rigid material, such as metal,plastic or polymer. After tool 130 is connected to manipulator distalend 136 and released from introducer 120, guiding element 148 may beremoved and manipulator can be freely maneuverable as illustrated inFIG. 3B. FIG. 3C illustrates a different type of an exemplary externalsupporting and/or guiding mechanism for manipulator 140 that includes asocket and a ball 151 design. Manipulator shaft 142 is passed through alumen in ball joint 151 and allowed to freely move. Manipulator shaft142 may be selectively paused in a specific orientation by deployingball-joint lock 153.

Reference is now made to FIG. 30-H schematically illustrating possibleapplications of external holding device 150 having a template arm 155.In some embodiments, template arm 155 is applied for coordinating arapid and accurate engagement of manipulator shaft 142 distal end and atool coupled to cartridge or any other coupling element 124 that isangularly connected to introducer body 122. In some embodiments, theengagement coordination includes guiding at least two members in body toa specific point and a specific angle in a 30 coordinate system withinbody 200 in order to allow the rapid and accurate engagement. In someembodiments, template arm 155 includes at least one introducer path 156and at least one manipulator path 158 that are located in the sameplane, optionally a perpendicular plane (e.g., a sagittal plane or atransverse plane) of patient body 200, optionally an anterior or aposterior plane. In some embodiments, at least one of introducer path(s)and manipulator(s) path(s) are at least partially circular therebyallowing a relative rotation of circular shaft therein. Additionally oralternatively, at least one of the paths includes a specific matingpattern (not shown), for example a recess, a protrusion or anynon-axisymmetrical shape, thereby allowing sliding of a shaft therein,the shaft having a mating cross section in a specific predeterminedsliding plane into body.

FIG. 3D illustrates a template arm 155 having a single introducer path156 and a single manipulator path 158, that are angled one with respectto the other in a same plane. In some embodiments, trocar body 112 isinserted through introducer path 156 thereby channeling introducer body122 into patient body 200. In some embodiments, introducer body 122 iscoupled to an interchangeable tool (not shown) via a tool couplingelement 124 that takes an angular orientation with respect to introducerbody 122 when it is completely emerged in body 200 through trocar body122. In some embodiments, manipulator shaft 142 is inserted throughmanipulator path 158 and travels into body 200 in an angled orientationtowards coupling element 124. In some embodiments, coupling element 124(and/or a tool coupled to and/or an inner passage of the tool) are insame angle and same plane as manipulator shaft 142 when are insertedthrough paths 156 and 158, respectively, of template frame 155. In someembodiments, at least one of paths 156 and 158 includes a guiding slot,recess, projection, etc. (not shown) that necessitates tool-manipulatorengagement in same point and/or angle and/or plane within body 200.Additionally or alternatively, markings are used to allow instrumentsmanipulation within body to the desired tool-manipulator orientation.

In some embodiments, template arm 155 is rotational around path 156 inorder to allow penetration points of same or different manipulator(s)shaft(s) 142 around said rotational axis. FIGS. 3E-3G suggest differenttemplate arms 155 a, 155 b and 155 c, which further allow penetrationports at different lengths along its longitudinal axis. In this way, anoperator may use a single template arm to insert a plurality ofmanipulators at different penetration ports (e.g., as illustrated inFIG. 4B) which are located in different angles and lengths with respectto tool introducing port 210 b.

FIG. 3E illustrates a template arm 155 a having a single introducer path156 and a plurality of manipulator paths, in this case three manipulatorpaths 158 a, 158 b and 158 c. In some embodiments, at least some of themanipulator paths are angled in such a way that manipulator passingtherethrough will engage a tool in the same depth but in a differentangle (so at least two paths will have different angles) or in adifferent depth but in the same angle (so at least two paths will havesame angles), or any combination thereof. FIG. 3F illustrates a templatearm 155 b having a single introducer path 156 and at least one,optionally a single, manipulator path 158. In some embodiments, templatearm 155 b has at least two pats, a first part that includes path 156 anda second part that includes path 158, that are telescopically connected,thereby allowing a selective distance alternation between the two paths.

FIG. 3G illustrates a template arm 155 c having a similar approach toarm 155 b, but uses at least two members jointly coupled to allow aselective distance alternation between introducer path 156 andmanipulator path 158.

In some embodiments, for example when a template arm having a singlemanipulator path 158 is used, an operator may still choose a path angle.In some embodiments, path 158 is angled, either automatically ormanually, using a mechanism (not shown) which correlates the distancebetween paths 156 and 158 and/or the depth of tool coupling element 124and/or the angle of coupling element 124. Alternatively or additionally,manipulator insertion angle may be altered while using a constantmanipulator path 158 angle, using angle adaptors 143 that are assembled(permanently or detachably) to a portion of manipulator shaft 142 (asillustrated in FIG. 3H).

(b) Exemplary Micro-Laparoscopy Approach

The present invention will provide descriptions for laparoscopiccholecystectomy procedures, although it should be clear that theproposed treatment and medical tools can be applied in many differentminimally invasive and/or anterior and/or endoscopic surgicalprocedures.

FIG. 4A illustrates a prior-art laparoscopic cholecystectomy procedurewhich utilizes a minimal sum of four laparoscopic ports:

-   -   (1) An endoscope port 210 a of approximately 10 mm in diameter,        usually located at patient's umbilicus. Port 210 a allows        insertion of a trocar by which an endoscope may be inserted into        body;    -   (2) A main operating port 220 a, approximately 10 mm in        diameter, usually located below the sternum. Port 220 a allows        insertion of different types of surgical and other instruments,        for example tools for suction, clipping, dissecting, cutting and        hooking;    -   (3) Two graspers ports 230 b, approximately 5 mm in diameter        each, usually located adjacently below the right-lateral ribs.        Commonly, two graspers are delivered through ports 230 b to        grasp and hold the gall bladder in a certain position prior to        executing surgical intervention steps.

In a normal laparoscopic cholecystectomy, the abdomen is first inflatedwith C0₂ via a 2.5 mm special-purpose Veres-needle, followed by openingof ports 210 a, 220 a and 230 a. An endoscope is then inserted throughport 210 a. After the abdomen is thoroughly scanned, graspers areintroduced through ports 230 a. A first grasper grasps the gall bladderat the Fundus region and then stretches and pushes it over the liver. Asecond grasper grasps the gall bladder at the Infundibulum region tomaneuver it laterally towards abdomen walls, thereby uncovering thecystic duct and the cystic artery. Several surgical instruments are thenserially introduced via port 220 a. At first, a dissector is used toseparate between the cystic duct and artery, a clipper is thenintroduced to block inflow of duct and artery, later to be both cut byscissors. Finally, the gall balder is separated using hooks or scissorsand removed from patient body through port 210 a (either as a whole orin pieces).

The use of a combined single-port laparoscopy and needlescopyapproaches, allows the surgeon more flexibility in choosing alaparoscopic ports scheme that may be procedure-specific and/orpatient-specific. For example, the use of slender manipulators allowsmore flexibility in choosing a number of manipulators and associatedtools to be applied simultaneously or in sequence while optionallycovering larger or smaller operated regions. Furthermore, more imagingand/or illumination sources may be introduced and operated at differentregions within abdomen, thus allowing improved visual monitoring ofprocedure and tool handling within body. Once a camera is situatedwithin body (e.g., via a needlescopic port) and abdomen cavity isadequately monitored, an endoscope may be considered unnecessary or bepulled in and out the single laparoscopic port for sequential toolsintroductions into the abdomen through this port.

FIG. 4B illustrates an optional exemplary porting scheme forlaparoscopic cholecystectomy, which may be advantageously utilized usinga rapid micro-laparoscopy approach of the present invention:

-   -   (1) A tools introducing port 210 b of approximately 10 mm in        diameter, usually located at patient's umbilicus. Port 210 b        allows insertion of a trocar by which tools (e.g., tools 130)        may be sequentially inserted into body optionally followed by an        endoscope. The 10 mm port may serve to introduce regular size        instruments such as clippers, Ligasure/harmonic scalpel,        suction, electrosurgical hook, etc.;    -   (2) At least one camera port 220 b of approximately 1 mm in        diameter, usually located adjacently below the left-lateral        ribs. A micro-camera (sized 1 to 10 mm in diameter) may be        inserted though port 210 b using a tool introducer (e.g.,        introducer 120) and transferred to a manipulator that is        operated and/or protruding through port 220 b. Alternatively or        additionally, an even smaller camera (sized 1 mm or less) may be        delivered into body directly though the 1 mm incision of port        220 b;    -   (3) At least two graspers' ports 230 b of approximately 2 mm in        diameter each, usually located adjacently below the        right-lateral ribs. Similarly to the micro-camera, the graspers        may be delivered through port 210 b and connected to        manipulators protruding through ports 230 b.    -   (4) Optionally one or more illuminator ports 240 b for holding        illumination source, such as LED illumination, IR light, regular        light, fiber optics etc. Port 240 b is approximately 1 mm in        diameter and located adjacently to port 220 b, also below the        left-lateral ribs. This may be especially useful in case that        the mini-camera does not include indigenous illumination        capabilities, for example in view of the importance to minimize        its size.

In some embodiments, similarly to normal laparoscopic cholecystectomy,the abdomen is first inflated with C02 using a 2.5 mm special-purposeVeres-needle. Camera and illumination manipulators are then introducedthrough 1 mm incisions made as ports 220 b and 240 b, respectively. Port210 b is then opened and a trocar is introduced. An interchangeablemini-camera and illumination are then introduced via the trocar at port210 b and connected to corresponding manipulators distal ends protrudingat ports 220 b and 240 b. Two 5 mm sized interchangeable graspers maythen be introduced via port 210 b and connected to correspondingmanipulators distal ends protruding at ports 230 b. The rest of thesurgical procedure steps may be carried out as in the prior art approachpreviously described, while “regular” laparoscopy instruments areinserted to abdomen and manipulated via port 210 b. Alternatively, atleast one interchangeable surgical tool replaces a “regular” laparoscopyinstrument and delivered to abdomen cavity later to be connected to acorresponding needlescopic manipulator that is located at a specialpurpose port (not shown) according to need and/or surgeon choice.

In some embodiments, an external holding device or template 150 is usedfor any of the purposes previously described, whereas a specifictemplate frame 154 design and/or template frame 155 are chosen and/orassembled at-site according to the requested laparoscopic portingscheme.

(c) Exemplary Deployment of a Rapid Micro-Laparoscopy System

Reference is now made to FIGS. 5A-F illustrating an exemplary rapidmicro-laparoscopy system 100 and steps of introduction of toolstherethrough. For demonstrative purposes, in FIGS. 5A-C a tool itself isnot illustrated.

In some embodiments, after deployment of system 100 as previouslydescribed, a trocar 110, having a tubular body 112 of about 10 mm indiameter, is introduced through port 210 b thereby allowing a safepassage of laparoscopic tools and instrumentation into body. Optionally,an introducer 120 having a body 122 of about 5 to 9 mm in diameter isinserted through trocar 110. Optionally, body 122 is tubular with aninner diameter of equal or less than 8 mm, optionally about 5 mm, andallowing insertion therethrough of endoscope 128 which is about 8 mm orless in diameter. In some embodiments, endoscope 128 is a side-visionendoscope having a lens 129 projected through a special lateral opening127, and can provide monitoring for the tool exchange within body vialateral window(s) 125 of body 122. Body 122 includes a distal end 126that is pivotally connected to tool cartridge 124 currently illustratedwithout a tool for demonstrative purposes.

Phase A of a tool delivery is illustrated in FIG. 5A where an assemblyof introducer body 122, endoscope 128 and cartridge 124 are traveledwithin trocar body 112 lumen towards abdomen cavity.

Phase B of tool delivery is illustrated in FIG. 5B where cartridge 124almost entirely protrudes out of trocar 110 lumen. Tool introducerdistal end 126 including lateral window 125 also protrudes, so endoscopemonitoring may be initiated.

In Phase C (FIG. 5C), cartridge 124 is oriented with respect to thelongitudinal axis of trocar-introducer assembly after entirely protrudedinto body cavity. In some embodiments, a released potential energy baseddevice (e.g., a released spring motion; not shown) is used for a passivecartridge 124 altering to a specific, optionally predefined orientation,optionally further using any orientation control mechanism (such as amotion limiter, a designated cam, an electronic control element, etc.).Alternatively or additionally, cartridge 124 alternation is activelyperformed either manually or remotely via a robotic arm. In someembodiments, cartridge 124 and/or the encapsulated tool longitudinalaxis are substantially parallel or concentric to manipulator shaft 146,thereby allowing a rapid engagement and connecting therebetween, assuggested in phase D (FIG. 5D).

The last delivery phase E (FIG. 5E) takes place once or after tool 130is appropriately connected to manipulator shaft 146. In a firstembodiment, two distinct locking mechanisms (not shown) are situated incartridge 124 and/or tool 130 and are used for locking the tool tocartridge 124 and to manipulator shaft 146, respectively. In a secondembodiment, the two locking mechanisms are interrelated in a way thatwhen a first lock is in locked mode the second lock is in released mode,and vice versa, thus allowing a “handoff” passing of the tool in asecure way.

Once phase E is complete, and tool 130 is connected to manipulator 140and disconnected from introducer 120, the tool may be utilized to itsdesignated task. In case that an external template 150 is used forguiding manipulator shaft 146 towards tool 130, the guiding element(e.g., guiding sleeve 148) may be released or removed, thereby allowingrelatively free movement of manipulator shaft 146.

(d) Exemplary Tool Handoff Delivery

Reference is now made to FIG. 6 that illustrate a side view and acorresponding top cut-view of an exemplary tool 1300 nested in anexemplary cartridge 1240 that is connected and/or part of an exemplarytool introducer 1200 having a body 1220. An exemplary needlescopicmanipulator shaft 1400 is proximately distant and optionally concentricto tool 1300 suggesting an initial pre-connecting phase (e.g., phase Cas previously described).

In some embodiments, cartridge 1240 is pivotally connected to introducerbody 1220 with a pivot 1210 thereby allowing at least partial rotationaround pivot 1210 axis. Optionally, cartridge 1240 rotation isaccomplished using a spring mechanism (not shown) or by any other meansknown to art. Optionally, a desired 30 cartridge/tool orientation isaccomplished by maneuvering cartridge 1240 from outside patient body,either manually or remotely.

In some embodiments, tool 1300 is an interchangeable grasper having ahead 1320, body 1340 and an inner passage 1360 capable of telescopicallyaccommodating a distal tip of manipulator 1400. Optionally, grasper 1300is approximately 5 mm in diameter. In some embodiments, for example asillustrated in FIG. 6, only grasper head 1320 is encapsulated bycartridge 1240, within cartridge tool head housing 1242, whereas atleast part of grasper body 1340, optionally most or all its length,extends outwardly within body cavity. Cartridge 1240 may further includea tool grasper 1270 for locking grasper head 1320 within housing 1242 orselectively releasing it when deployed.

Reference is now made to FIG. 7A illustrating a top cut-view of grasper1300, having a tubular frame 1342, nested in cartridge 1240 whileinterlocked with a manipulator distal tip 1460. Optionally, tool 1300includes a beveled tool opening 1362 for an easier accommodation ofmanipulator distal tip 1460. In some embodiments, tool 1300 includes amanipulator tip lock 1370 situated along a portion of inner passage1360, for snap-locking to a distal tip of manipulator 1400, using a lockbeveled opening 1372 and a lock narrow section 1374 which is designed tomate with a corresponding recess 1462 located proximally to manipulatortip 1460. In some embodiments, tip lock 1370 is connected at itsproximal side to a tool inner shaft 1380 and is blocked from movingdistally by a releasing mechanism lock widener 1394 shown in FIG. 7 in alocking position. In some embodiments, lock widener 1394 has a roundedportion 1396 for an optional selective smoother proximal travel withinlock beveled opening 1374. In some embodiments, lock widener is coupledto a releasing mechanism outer sleeve 1392 that is rotatable around toolbody tubular frame 1342.

When locked to manipulator 1400, grasper 1300 may now be released fromtool cartridge 1240 as illustrated in FIG. 8. In some embodiments, whengrasper 1300 is distally pulled (e.g., by manipulator 1400) it easilydisconnects from cartridge 1240 by laterally widening cartridge toolgrasper 1270 during pullout. Optionally, a threshold force is requiredfor achieving disconnection in order to avoid unintentional tool escapesfrom cartridge grasping.

Additionally or alternatively, grasper release is achieved by unlockinga second locking mechanism that releasably holds it within cartridgehousing 1242. FIGS. 7B and 7C illustrate another exemplary design formanipulator 1400 in unlocked and locked modes, respectively. In someembodiments, manipulator 1400 includes an inner shaft 1422 having adistally pointed end 1460, an intermediate sleeve 1466 having a distalcompressible portion 1464 and optionally maintains substantially sameouter diameter with shaft 1422 maximal diameter, and an outer sleeve1424. In some embodiments, compressible portion 1464 expands and/or sendarms when compressed, thereby produced interlocking when engaged into arecess in a smaller diameter lumen. Optionally, compressible portion1464 includes a tubular portion that is elastic and/or braided and/orslitted and/or bellowed (i.e., includes bellows). Optionally,compressible 1464 includes a stent-like design, optionally a cage-likedesign, optionally includes at least one strip that is bendable to anarch. Optionally, outer sleeve 1424 is connectable to tool 1300 andallows rotatability to an inner rotatable part and/or a sliding movementof an inner slidable part of tool 1300. Optionally, outer sleeve rotatesand/or slides with respect to shaft 1422 and/or intermediate sleeve 1466thereby allowing operation of tool 1300 and/or locking/unlocking modesshift. Optionally, locking and unlocking are achieved by relativemovement of shaft 1422 and intermediate sleeve 1466 (e.g., by pulling orpushing sleeve 1466 proximal end).

(e) Exemplary Tool Removal

In some embodiments, after final utilization of a tool and/or atprocedure termination the tool should be disconnected from itscorresponding manipulator 1400 and be safely removed from body via toolintroducing port 210 b. Optionally, special removing device and/or toolgrasping cartridge are used (not shown). Alternatively, sameinstrumentation is used in a substantially reverse order for tool(s)removal. Reference is now made to FIG. 9 illustrating a side view ofgrasper 1300 connected to manipulator 1400 while pressed againstcartridge 1240. In some embodiments, cartridge tool grasper 1270includes a tool opening teeth 1272 including beveled end portions 1274allowing tool grasper widening when grasper head 1320 is pressed againstit with a force that exceeds a defined threshold force.

Now that grasper 1300 is re-nested in cartridge 1240 a second mechanismis operated for releasing the grasping of manipulator tip 1460 anddisconnecting from manipulator 1400, as illustrated FIG. 10. In someembodiments, releasing mechanism outer sleeve 1392 includes a diagonalslot 1397 that is engaged with a pin 1398 laterally projecting from toolbody inner shaft 1380. Optionally, outer sleeve 1392 and inner shaft1380 can slide and/or rotate one with respect to the other, so that pin1398 travel from a first corner (position I1 in FIG. 10C) to a secondcorner (position I2 in FIG. 10D) of diagonal slot 1397 is accomplishedby a proximal partial sliding of inner shaft 1380 and its rotationcounter-clockwise partial rotation with respect to outer sleeve 1392.

In some embodiments, tool body tubular frame 1342 includes an L-slot1344 that is engaged with a pin 1382 laterally projecting from tool bodyinner shaft 1380. Optionally, tubular frame 1342 and inner shaft 1380can slide and/or rotate one with respect to the other, so that pin 1382travel from a first corner (position J1 in FIG. 10C) to a second corner(position J2 in FIG. 10D) of L-slot 1344 is accomplished by a proximalpartial sliding of inner shaft 1380 and its rotation counter-clockwisepartial rotation with respect to tubular frame 1342.

Since that pin 1398 and pin 1382 are both projections of inner shaft1380, a counter-clockwise rotation of the inner shaft promotes arelative inward motion between tool frame 1342 and outer sleeve 1392.Referring back to FIG. 7A, releasing mechanism lock widener 1394 issituated with respect to lock beveled opening 1372 in a manner thatcorresponds to positions I1/J1 (FIG. 10C). In some embodiments, lockwidener 1394 is firmly connected to outer sleeve 1392 in a manner thatdenies lengthwise movement between them, so that when frame 1342 andouter sleeve 1392 are moving inwardly, lock beveled opening 1372 andlock widener 1394 are moving inwardly as well, resulting in widening ofopening 1372 by widener 1394. This allows manipulator tip 1460 removalfrom tool inner passage 1360, so that tool 1300 may be removed from bodyvia port 210 b. FIG. 10E illustrates the widening of opening 1372 bywidener 1394 in a manner that corresponds to positions 1232 (FIG. 10D).

In some embodiments, the lengthwise and/or rotational movement of innershaft 1380 (hence of pins 1398 and 1382) is executed by a correspondingmotion of a manipulator body 1420. As shown in FIG. 10F, body 1420comprises a shaft 1422 and an outer sleeve 1424, optionally capable ofrelative rotation. In some embodiments, tool inner passage 1360 includesat least one tenon 1364 which engages corresponding recesses or slots(not shown) on manipulator outer sleeve 1424, thereby denying rotationalmovement between them. Hence, in some embodiments, when manipulator 1400is traveled inward and/or counter-clockwise rotated, tool inner shaft1380 follows the same movement and consequently manipulator 1400 isdisconnected from tool 1300 and may be easily pulled out.

(f) Other Exemplary Embodiments

In some embodiments, the system is connectable and/or is part of asurgical robotic system and/or a telesurgery system. In an exemplaryembodiment, at least one of: introducer, tool, tool-cartridge,manipulator, template, template arm, are controlled and/or operatedrobotically and/or remotely.

In some embodiments, the system includes at least partial fail-prooflocking mechanisms, for example between the tool and the tool-cartridgeand/or between the tool-cartridge and the introducer and/or between thetool and the manipulator distal end. In an exemplary embodiment, alocking mechanism is normally opened, hence in a fail-mode will resumeunlocked mode, or vice versa.

In some embodiments, a system locking mechanism includes pneumaticand/or hydraulic and/or electronic components. Optionally the lockingmechanism includes sensors which detect connection and/or disconnectionsof two elements (e.g., tool and cartridge, tool and manipulator,cartridge and introducer, etc.). Optionally, in a fail-mode situation, apassive locking mechanism may be bypassed with a different activelocking mechanism (e.g., remotely manually operated), and vice versa.

In some embodiments, the system is designed to allow only a specificsequence of steps. One of many sequences may include the step ofconnecting and/or deploying a template arm in a specific manner;followed by the step of introducing an introducer into body and pivotingcartridge to a predetermined orientation in body; followed by the stepof introducing a manipulator shaft using the template arm to directlyengage and connect to the tool nested or connected to the cartridge;followed by the step of releasing the tool from the cartridge. In someembodiments, this “one-way” sequence may be applied by using a controlmechanism that allows a proper utilization of a second locking elementonly after a first locking element was properly utilized, and viceversa.

(g) Exemplary Positioning of the Tool-Introducer

System 1000 is deployed prior to utilization in a body cavity, forexample, an abdominal cavity 2000. System 1000 includes a laparoscopicworking channel or port, referred to here as, but not limited to, atrocar 1100, and at least one handheld micro-laparoscopic manipulatorreferred to as tool manipulator 1400. Tool manipulator 1400 includes ashaft 1420 and an operation handle 1440. Shaft 1420, such as a slendershaft, is configured to be attached at its distal end to a detachableand/or an interchangeable surgical end-effector or tool (not shown). Insome embodiments, the tool manipulator could be configured as describedherein in respect to FIGS. 6-10.

In FIG. 11A, trocar 1100 and tool manipulator 1400 are positioned afterinsertion into abdominal cavity 2000 and prior to attachment of a tool.Optionally, trocar 1100 may be housing an endoscope (not shown). Inorder to attached the tool to the distal end of shaft 1420, the surgeonneeds to position it adjacent to the lumen of trocar 1100 by aimingtowards the endoscope lens (or “towards his eye” as seen in themonitor). Optionally, the endoscope is then withdrawn from trocar 1100.A tool introducer then introduces a tool through the path of the trocar1100. In some embodiments the endoscope is deployed in the toolintroducer. In some further embodiments the introduction of a tool andthe transfer of the tool between a tool introducer and the shaft 1420could be performed according to any of the methods described herein.

A tool may be any operational element (e.g., a probe or an instrument)deployable within a body, including but not limited to: surgical tools,grasping elements, dissectors, needle holders, clippers, scissors,connecting (e.g., stapling) elements, biopsy related instruments, sensorelements, imaging elements, clamping, clipping elements or graspingdevices, heat generating probes (including RF, laser, IR, light, etc.),cryogenic probes, illuminating elements cutting and dissecting devicesor energy sources, ultrasound probes, camera or other imaging probes,lenses, lenses tubes, or any other optical instruments, etc.

Trocar 1100 may be of any preferred size, and usually between 3 mm to 20mm in diameter, optionally about 10 mm or 12 mm (e.g., similar in sizeto regular laparoscopic port). Trocar 1100 may be sized (e.g., smallestcross section) to accommodate a largest of a surgical tool in a specifictool kit. In some embodiments, system 1000 includes a singleregular-sized laparoscopic port that may be utilized for tool(s)insertion into the body and/or connection to the tool manipulator 1400.

In some embodiments, shaft 1420 includes a distal tip. The largest crosssection of the shaft and tip may be 0.5 mm to 5 mm in diameter,optionally 1 to 2.5 mm, optionally about 1 mm, about 1.5 mm or about 2mm or higher or lower or intermediate. The shaft tip is optionally sharpand/or pointed in order to allow at least one of tissue penetration andeasier engagement with a tool. Optionally, the shaft tip is a Veresneedle which optionally permits penetration through skin and abdominalwall tissue while preventing injury of internal organs (e.g., bowels)when not “armed”. Optionally, shaft 1420 includes interlocking means,e.g., threading or a groove for snap-locking (not shown), for firmlyconnecting with the tool, or alternatively by any means of friction,pressure or other means known to the art. Handle 1440 may be anymanually operated type laparoscopic instrumentation handle or may bereplaced with any robotic or other non-manually operated arm. In someembodiments, handle 1440 includes mechanisms which operate theintroduced tool(s) and/or their association (e.g., locking or releasingmodes or operations).

At least part of the instruments are made from rigid biocompatiblematerials as known to a person skilled in the art, and may includestainless steel, optionally hardened or reinforced by carbon coating orfibers, ceramic materials, plastic/polymeric materials (e.g., PEEK),composite materials (e.g., carbon-epoxy), or any combination thereof.

In some situations, the process of maneuvering the tool manipulator 1400until locating the trocar 1100 may be difficult, time consuming and/orunsafe, due to the possibility that the shaft 1420 may harm adjacenttissues. Reference is now made to FIGS. 11B-C, illustrating different(partial) deployment stages of a second schematically illustratedexemplary micro-laparoscopic system, in accordance with an exemplaryembodiment of the invention. This embodiment comprises an elongated toolintroducer 1200 (as shown in the figures.) and/or an elongated trocar1100 (not shown). An elongated tool introducer 1200 assists in locatingand guiding distal end of shaft 1420 before transferring the tool to theshaft 1420. The elongated tool introducer 1200 is introduced via trocar1100, and travels into the abdominal cavity 2000 until it is adjacentthe distal end of shaft 1420 (as shown in FIG. 11B). In this embodiment,an endoscope (not shown) may be placed inside the elongated toolintroducer 1200. Additionally and/or alternatively an elongated trocar1100 could be used to locate and guide the distal end of shaft 1420before introducing the tool introducer 1200 into the lumen of the trocar1100. If an elongated trocar 1100 is utilized an endoscope could in someembodiments be placed inside the trocar 1100.

Additionally or alternatively to using an elongated trocar 1100 and/oran elongated tool introducer 1200, other locating and/or guiding and/orgrasping/connecting devices (not shown) may be used to locate and/orguide and/or grasp shaft 1420 in the abdominal cavity 2000 and assist intransferring and engaging the interchangeable tool.

FIG. 11C suggests a slightly different approach using a substantiallylonger or more distally advanceable elongated tool introducer 1200′(shown) and/or elongated trocar 1100 (not shown), which is sized and/orconfigured to advance towards and to reach at and/or capture theinlet/incision or a position adjacent to the inlet/incision ofmanipulator 1400 through and into abdominal cavity 2000, so the tip ofthe shaft 1420 may be captured at the entry of the abdominal cavity2000, located at the periphery of the abdominal cavity 2000. In someinstances it will be preferable to use this approach, as may beimportant not only to prevent injury to organs but also to preventworking against the direction of viewing which may be consideredcumbersome.

In some embodiments the release, transfer and engagement of theinterchangeable tool could then be performed according to any of themethods described herein. Alternatively, such release, transfer andengagement may be performed in other methods known to the art.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

What is claimed is:
 1. A system for positioning an interchangeable toolin a body cavity, the system comprising: a channel comprising a lumenfor direct communication with said body cavity; a tool introducercomprising a longitudinal axis and a distal end, said tool introducer iscapable of traveling through said channel lumen; and a tool holderengaging at least a portion of said interchangeable tool, said toolholder is pivotally connected to said tool introducer distal end forangular positioning said interchangeable tool relative to the toolintroducer in said body cavity after said tool holder emerges from saidchannel, and an external guiding device configured to guide a toolmanipulator to engage said interchangeable tool in said body cavity,said external guiding device comprising a center guide comprising afirst lumen adapted to accommodate said channel, and an adjustableperipheral guide having a proximal end connected to said center guideand a distal end incorporating a second lumen, wherein said toolintroducer is distally connected to said interchangeable tool andreadily deployable in said body cavity through said channel accommodatedin said first lumen of said center guide, and wherein said adjustableperipheral guide is adjusted to guide said tool manipulator through saidsecond lumen to engage said interchangeable tool.
 2. The systemaccording to claim 1, wherein said angular positioning is predetermined.3. The system according to claim 1, wherein said angular positioning isconstant.
 4. The system according to claim 1, wherein said angularpositioning is selectively chosen after said tool holder emerges fromsaid channel into said body cavity.
 5. The system according to claim 1,wherein said interchangeable tool comprises one of the group consistingof a grasper, a dissector, a needle holder, scissors, a camera, anendoscope, a heat source, a sensing probe, a cryogenic probe, adissector, a biopsy probe, a cutting tool, a laser source, an IR source,a light source, an illumination source, an ultrasound probe, anelectrocautery device, a drug delivery device and combinations thereof.6. The system according to claim 1, wherein said external guiding deviceis further adapted to guide a distal portion of said tool manipulator ina defined orientation and/or depth in said body cavity.
 7. The systemaccording to claim 6, wherein said external guiding device is adapted toselectively lock said distal portion of said tool manipulator in saidorientation and/or depth.
 8. The system according to claim 6, whereinsaid distal portion of said tool manipulator is concentric to an innerpassage of said interchangeable tool.
 9. The system according to claim1, wherein said second lumen includes a longitudinal axis that is angledtowards said center guide in at least one dimension.
 10. The systemaccording to claim 1, wherein said adjustable peripheral guide isadjustable by at least one of: lengthening, bending, tilting, rotating,deforming and/or any combination thereof.
 11. The system according toclaim 1, wherein said tool introducer comprises a tubular section. 12.The system according to claim 11, and further comprising an endoscopedeployable in said tubular section.
 13. The system according to claim12, wherein said tubular section includes a window, thereby enablingendoscopic visualization by said endoscope.
 14. A method for engaging aninterchangeable tool, said tool having an inner passage, with a distalportion of a tool manipulator extended into a body cavity via amanipulator opening, said method comprising the steps of: inserting atool introducer into a channel, said channel comprising a lumenproviding direct communication into said body cavity and wherein aproximal end of said interchangeable tool is reversibly connected to adistal end of said tool introducer; emerging said interchangeable toolfrom said channel into said body cavity; and positioning saidinterchangeable tool to said lumen of said channel, wherein said innerpassage of the interchangeable tool is angled towards said distalportion of said tool manipulator, and wherein said manipulator openingis located remote from said channel.
 15. The method according to claim14, wherein said positioning is automatically executed once saidinterchangeable tool entirely emerges from said channel.
 16. The methodaccording to claim 14, wherein said positioning is selectively executedby an operator.
 17. The method according to claim 14, and furthercomprising predetermining an angle of said positioning of saidinterchangeable tool.
 18. The method according to claim 14, comprisingusing a constant angle for said positioning of said interchangeabletool.
 19. The method according to claim 14, and further comprisingselectively choosing an angle of said positioning of saidinterchangeable tool after emerging said interchangeable tool.